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Risk Analysis - FMEA

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by

Tim Dubbs

on 27 May 2011

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Transcript of Risk Analysis - FMEA

Risk Analysis - FMEA 10 Step Process Failure Mode & Effects Analysis Every product or process has modes of failure. The effects represent the impact of the failures. An FMEA is a tool to:

Identify the relative risks designed into a product or process.
Initiate action to reduce those risks with the highest potential impact.
Track the results of the action plan in terms of risk reduction. FMEAs help us focus on and understand the impact of potential process or product risks. A systematic methodology is used to rate the risks relative to each other. An RPN or Risk Priority Number is calculated for each failure mode and its resulting effect(s). The RPN is a function of three factors: The Severity of the effect, the frequency of Occurrence of the cause of the failure, and the ability to Detect (or prevent) the failure or effect. Design-FMEAs

The primary objective of a Design-FMEA is to uncover potential failures associated with the product that could cause:

Product malfunctions.
Shortened product life.
Safety hazards while using the product.
Cause customer dissatisfaction Process-FMEAs

Process-FMEAs uncover potential failures that can:

Impact product quality.
Reduce process reliability.
Cause customer dissatisfaction.
Create safety or environmental hazards. Step 1: Review:

Help assure all team members are familiar with the product and its design.
Identify each of the main components of the design and determine the function or functions of those components and interfaces between them.
Make sure you are studying all components defined in the scope of the DFMEA. Step 2: Brainstorm Potential Failure Modes:

Consider potential failure modes for each component and interface.
A potential failure mode represents any manner in which the product component could fail to perform its intended function or functions.
Remember that many components will have more than one failure mode. Document each one. Do not leave out a potential failure mode because it rarely happens. Step 3: Effects

The effect is related directly to the ability of that specific component to perform its intended function.
An effect is the impact a failure could make should it occur.
Some failures will have an effect on customers; others on the environment, the process the product will be made on, and even the product itself.

The effect should be stated in terms meaningful to product performance. If the effects are defined in general terms, it will be difficult to identify (and reduce) true potential risks. Step 7: Calculate the RPN ( RPN = S * O * D)

The RPN is the Risk Priority Number. The RPN gives us a relative risk ranking. The higher the RPN, the higher the potential risk. Step 6: Step 5 Step 4: Step 8: Develop the Action Plan

Taking action means reducing the RPN. The RPN can be reduced by lowering any of the three rankings (severity, occurrence, or detection) individually or in combination with one another. The FMEA Cycle Risk Analysis: Where to Start? The End ? PreWork - Team FMEA Pitfalls and Limitations

Prioritizes, Doesn’t Correct
- The initial output of an FMEA is the prioritizing of failure modes based on their risk priority numbers.
This alone does not eliminate the failure mode. Additional action that might be outside the FMEA is needed.

Only as Good as the Team

Time Consuming

Unknown Unknowns

Not Starting in the Design Stage

Taking on Too Large a Scope

Not Including Customers

Not Using Concept of a Process
- This will cause the team to forget some failure modes.
The team should brainstorm failure modes in each of People, Methods, Equipment, Materials, and Environment.

Not Getting into the Details

Confusing Root Cause and Failure Mode

Pitfall 21 Failing to Update the FMEA Today:

Team Setup
Deside on Template
Review Process/components
Initial FMEA Questions
Brainstorm FM&Es per component
Full transcript